SUMMARY
This leading global pharmaceutical company is looking for a strong Analytical Scientist to join their R&D team in support of their ever growing portfolios of pharmaceutical drug products across a wide range of therapeutic areas. The ideal candidate will have a Ph.D. with at least 1-2 years of hands-on experience with solid orals/semi-solids for small molecules OR Masters +4-6 years.
RESPONSIBILITIES
- Lead analytical development activities while providing supervision, training, & leadership to the jr. chemists.
- Identifies analytical test method goals to support the different product development stages and develops accurate and robust analytical test methods
- Performs complex analytical testing with accuracy and efficiency
- Provides a high level of experimental design and data interpretation
- Participate in cross functional meetings and provide input on strategy implementation for various projects where needed.
- Author & review relevant technical documents/SOP's & FDA submissions
QUALIFICATIONS
- Ph.D. in Pharmaceutical Sciences (Or equivalent/relevant degree) with 1-2 years of small molecule analytical development experience in the pharma industry OR M.S. +4-6 years.
- Expertise in key analytical techniques such as HPLC, LC-MS, dissolution studies, XRPD, DSC, IR, etc.
- Strong communication skills (written & verbal)
- Experience with additional dosage forms (nasal, topical, injectable, liquid solutions, etc.) is a major plus!-Solid Orals are a MUST.
- Experience with NDA/ANDA/505(b2) is HIGHLY DESIRED!